FDA calls for more American-made pharmaceuticals to shore up supply chain
Greater production domestically will help reduce reliance on global supply chains for medications that are in short supply.
Government agencies release recommendations to shore up pharmaceutical supply chain The pandemic exposed vulnerabilities in the U.S. pharmaceutical supply chain. This week, the federal government released a series of policy recommendations to address those problems.
“Last year, the American people experienced a widespread and significant shortage of N95 respirators for health-care workers and masks to protect essential workers and others, and year after year we see shortages of medicines and medical supplies like saline,” FDA Acting Commissioner Janet Woodcock said. “Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country. Now is the right time to take action to keep the U.S. drug supply chain secure and resilient.”
Related: 2021 pharma forecast: Expect shortages and supply chain disruptions
HHS will make an initial commitment of approximately $60 million from the Defense Production Act appropriation in the American Rescue Plan to develop novel platform technologies to increase domestic manufacturing capacity for active pharmaceutical ingredients. Greater API production domestically will help reduce reliance on global supply chains for medications that are in short supply, particularly during times of increased public health need. To secure the supply chain, the report’s recommendations center on four pillars:
- Boosting local production and fostering international cooperation;
- Promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience;
- Creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance, and;
- Leveraging data to improve supply chain resilience.
Strengthening supply chains may require leveraging existing authorities, such as the Defense Production Act, as well as incentives that recognize and reward manufacturers for quality management maturity systems that focus on continuous improvement, business continuity plans and early detection of supply chain issues.
The recommendations also recognize that securing the supply chain may require new initiatives to collect specific data that support the private sector in improving resiliency and reducing the likelihood of shortages, especially during public health emergencies, to provide uninterrupted service to their customers.
The report and its recommendations were in response to an executive order focused on securing America’s critical supply chains. The order directed the administration to launch an immediate 100-day review and strategy development process to address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals. HHS will work with the private sector and Congress to implement the recommendations and develop a strategy to facilitate adoption of novel methods for commercial production of pharmaceuticals and biologics.
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